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Elastic Separator in module Light Blue - Ø 5/32" = 4, 0mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.04.201Model SEPARATOR ELASTIC
Identity
- Trade Name
- Elastic Separator in module Light Blue - Ø 5/32" = 4,0mm EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Elastic Separator in module Light Blue - Ø 5/32" = 4,0mm FDA UDI
- Model / Reference
- SEPARATOR ELASTIC EUDAMED60.04.201 EUDAMEDFDA UDI
- Description
- Elastic Separator in module Light Blue - Ø 5/32" = 4,0mm FDA UDI
Identifiers
- Catalog Number
- 60.04.201 FDA UDI
- Primary DI / UDI-DI
- 07895742055899 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742179GR EUDAMEDB-07895742055899 EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic archwire/bracket ligature FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic retainer
Elastic Separator in module Light Blue - Ø 5/32" = 4, 0mm by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Orthodontic retainer.
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
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- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742179GR | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742179GR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED cc8b233c-e931-4d09-899a-36d12030b550 61 fields · synced Jul 21, 2026
- EUDAMED 584b5bbe-d4a7-4531-aea5-7717afbebbb0 61 fields · synced May 17, 2026
- FDA UDI 997404f1-7c56-49e6-9407-cf6419592f29 35 fields · synced May 30, 2026